EMDN U01: Urethral, Prostatic and Bladder Catheters

Registered classes, as of 8 Sep 2026. For each code with at least 20 registrations under a legislation, the chip shows how devices registered in EUDAMED under that code are classed, counted once per primary UDI-DI and kept separate for each legislation. It is not a determination. The class of a device comes from the MDR and IVDR classification rules for its intended purpose. MDD and IVDD classes are the directive classification and can differ from the class the same device would have under MDR or IVDR.

• U01Urethral, Prostatic and Bladder Catheters
  • U0101Urethral Prostatic and Bladder Catheters, without Balloon
    • U010101Urethral Prostatic and Bladder Catheters, Conical-Olivary Tip (Urethral Calibration)terminal
    • U010102Urethral Prostatic and Bladder Catheters, Couvelaireterminal
    • U010103Urethral Prostatic and Bladder Catheters, MalecotMDR 99.8% Class IIa · n=822terminal

      Registered in EUDAMED under MDR with this code: 821 of 822 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 821 Class IIa (99.8%)
      • 1 Class IIb (0.1%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

    • U010104Urethral Prostatic and Bladder Catheters, Mercierterminal
    • U010105Urethral Prostatic and Bladder Catheters, Nelaton
      • U01010501Nelaton Catheters, Self-LubricatingMDR 2 classes · n=2,026MDD 95.8% Class IIa · n=771terminal

        Registered in EUDAMED under MDR with this code, the 2,026 devices are split across classes (as of 8 Sep 2026).

        • 1,567 Class I (77.3%)
        • 459 Class IIa (22.6%)

        Registered in EUDAMED under MDD with this code: 739 of 771 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 739 Class IIa (95.8%)
        • 32 Class I (4.1%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • U01010502Nelaton Catheters, Non Self-LubricatingMDR 2 classes · n=931MDD 2 classes · n=206terminal

        Registered in EUDAMED under MDR with this code, the 931 devices are split across classes (as of 8 Sep 2026).

        • 469 Class IIa (50.3%)
        • 462 Class I (49.6%)

        Registered in EUDAMED under MDD with this code, the 206 devices are split across classes (as of 8 Sep 2026).

        • 134 Class IIa (65.0%)
        • 72 Class I (34.9%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • U010106Urethral Prostatic and Bladder Catheters, Tiemann
      • U01010601Tiemann Catheters, Self-LubricatingMDR 2 classes · n=344MDD 2 classes · n=184terminal

        Registered in EUDAMED under MDR with this code, the 344 devices are split across classes (as of 8 Sep 2026).

        • 324 Class I (94.1%)
        • 20 Class IIa (5.8%)

        Registered in EUDAMED under MDD with this code, the 184 devices are split across classes (as of 8 Sep 2026).

        • 171 Class IIa (92.9%)
        • 13 Class I (7.0%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • U01010602Tiemann Catheters, Non Self-LubricatingMDR 2 classes · n=140MDD 2 classes · n=29terminal

        Registered in EUDAMED under MDR with this code, the 140 devices are split across classes (as of 8 Sep 2026).

        • 114 Class I (81.4%)
        • 26 Class IIa (18.5%)

        Registered in EUDAMED under MDD with this code, the 29 devices are split across classes (as of 8 Sep 2026).

        • 24 Class IIa (82.7%)
        • 5 Class I (17.2%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • U010107Urethral Prostatic and Bladder Catheters, Pezzerterminal
    • U010199Urethral Prostatic and Bladder Catheters, not Self-Retained - OtherMDR 97.7% Class I · n=409MDD 3 classes · n=142terminal

      Registered in EUDAMED under MDR with this code: 400 of 409 devices carry Class I on their registration (as of 8 Sep 2026).

      • 400 Class I (97.7%)
      • 9 Class IIa (2.2%)

      Registered in EUDAMED under MDD with this code, the 142 devices are split across classes (as of 8 Sep 2026).

      • 73 Class IIb (51.4%)
      • 44 Class I (30.9%)
      • 25 Class IIa (17.6%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • U0102Urethral Prostatic and Bladder Catheters, with Balloon
    • U010201Urethral Prostatic and Bladder Catheters, Nelaton, with BalloonMDR 2 classes · n=399MDD 2 classes · n=1,043terminal

      Registered in EUDAMED under MDR with this code, the 399 devices are split across classes (as of 8 Sep 2026).

      • 276 Class IIa (69.1%)
      • 123 Class IIb (30.8%)

      Registered in EUDAMED under MDD with this code, the 1,043 devices are split across classes (as of 8 Sep 2026).

      • 741 Class IIb (71.0%)
      • 302 Class IIa (28.9%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • U010202Urethral Prostatic and Bladder Catheters, Couvelaire, with BalloonMDR 2 classes · n=312MDD 2 classes · n=92terminal

      Registered in EUDAMED under MDR with this code, the 312 devices are split across classes (as of 8 Sep 2026).

      • 275 Class IIa (88.1%)
      • 37 Class IIb (11.8%)

      Registered in EUDAMED under MDD with this code, the 92 devices are split across classes (as of 8 Sep 2026).

      • 49 Class IIa (53.2%)
      • 43 Class IIb (46.7%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • U010203Urethral Prostatic and Bladder Catheters, Delinotte, with BalloonMDD 100.0% Class IIa · n=20terminal

      Registered in EUDAMED under MDD with this code: 20 of 20 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 20 Class IIa (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • U010204Urethral Prostatic and Bladder Catheters, Dufour, with BalloonMDR 2 classes · n=25MDD 2 classes · n=73terminal

      Registered in EUDAMED under MDR with this code, the 25 devices are split across classes (as of 8 Sep 2026).

      • 19 Class IIa (76.0%)
      • 6 Class IIb (24.0%)

      Registered in EUDAMED under MDD with this code, the 73 devices are split across classes (as of 8 Sep 2026).

      • 44 Class IIa (60.2%)
      • 29 Class IIb (39.7%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • U010205Urethral Prostatic and Bladder Catheters, Mercier, with BalloonMDD 2 classes · n=25terminal

      Registered in EUDAMED under MDD with this code, the 25 devices are split across classes (as of 8 Sep 2026).

      • 20 Class IIb (80.0%)
      • 5 Class IIa (20.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • U010206Urethral Prostatic and Bladder Catheters, Tiemann with BalloonMDR 2 classes · n=56MDD 2 classes · n=200terminal

      Registered in EUDAMED under MDR with this code, the 56 devices are split across classes (as of 8 Sep 2026).

      • 47 Class IIb (83.9%)
      • 9 Class IIa (16.0%)

      Registered in EUDAMED under MDD with this code, the 200 devices are split across classes (as of 8 Sep 2026).

      • 151 Class IIb (75.5%)
      • 49 Class IIa (24.5%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • U010299Urethral Prostatic and Bladder Catheters, with Balloon - OtherMDR 3 classes · n=3,561MDD 2 classes · n=239terminal

      Registered in EUDAMED under MDR with this code, the 3,561 devices are split across classes (as of 8 Sep 2026).

      • 2,943 Class IIa (82.6%)
      • 599 Class IIb (16.8%)
      • 19 Class I (0.5%)

      Registered in EUDAMED under MDD with this code, the 239 devices are split across classes (as of 8 Sep 2026).

      • 154 Class IIa (64.4%)
      • 85 Class IIb (35.5%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • U0103Urethral Prostatic and Bladder Catheters with Temperature SensorsMDR 100.0% Class IIb · n=68MDD 100.0% Class IIb · n=45terminal

    Registered in EUDAMED under MDR with this code: 68 of 68 devices carry Class IIb on their registration (as of 8 Sep 2026).

    • 68 Class IIb (100.0%)

    Registered in EUDAMED under MDD with this code: 45 of 45 devices carry Class IIb on their registration (as of 8 Sep 2026).

    • 45 Class IIb (100.0%)

    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • U0180Urethral Prostatic and Bladder Catheters - AccessoriesMDR 2 classes · n=54terminal

    Registered in EUDAMED under MDR with this code, the 54 devices are split across classes (as of 8 Sep 2026).

    • 39 Class I (72.2%)
    • 15 Class IIa (27.7%)

    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

  • U0199Urethral Prostatic and Bladder Catheters - OtherMDR 2 classes · n=45terminal

    Registered in EUDAMED under MDR with this code, the 45 devices are split across classes (as of 8 Sep 2026).

    • 42 Class I (93.3%)
    • 3 Class IIa (6.6%)

    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.